Determining olive leaf extract effect on hemorrhoid
Design
A parallel randomized clinical trial with control group, double-blind; Phase 2-3, on 180 patients, the patients will be randomly assigned to intervention and control groups using block randomization.
Settings and conduct
This study is performed on grade 1 to 3 hemorrhoid disease in Shohada-ye Ashayer Hospital in Khorramabad. The patient and the examining physician will not be aware of the patient's type of drug treatment so the study will be double-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: grade 1-3 hemorrhoid disease, not taking hemorrhoid medication in the last 14 days, non-pregnant, having moderate to severe pain, age 18-65 years.
Exclusion criteria: History of allergy or anaphylaxis to the drugs used, lack of consent, suffering from other colon diseases
Intervention groups
Intervention group 1: cream containing Aburihan ointment and 1% olive leaf extract(Dana Kasian Company) for 21 days, 3 times a day;
Intervention group 2: cream containing Aburihan ointment and 2% olive leaf extract (Dana Kasian Company)for 21 days, 3 times a day;
Intervention group 3: cream containing Aburihan ointment and 4% olive leaf extrac(Dana Kasian Company)t for 21 days, 3 times a day;
Control group: anti-hemorrhoid ointment from Aburihan company for 21 days, 3 times a day.
Main outcome variables
pain; itching; bleeding; patient satisfaction; side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220724055547N1
Registration date:2022-11-14, 1401/08/23
Registration timing:registered_while_recruiting
Last update:2022-11-14, 1401/08/23
Update count:0
Registration date
2022-11-14, 1401/08/23
Registrant information
Name
Golsa Farzan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3322 8981
Email address
golsa.f.96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of olive leaf extracts on hemorrhoid disease symptoms
Public title
The effects of olive leaf extracts on hemorrhoid disease symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Grade 1 to 3 hemorrhoid disease
Not taking medicine for hemorrhoid disease in the last 14 days
Non-pregnant women
Having a moderate to severe pain score
age between 18 to 65
Exclusion criteria:
History of allergy or anaphylaxis to the drugs used
Lack of consent to participate in the study
Suffering from other colon diseases
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method will be used to implement random assignment. In this way, 180 consecutive numbers (from 1 to 180) will be written individually on paper and will be placed in a container. Then, each of the participants in the trial is asked to randomly select one of these 180 numbers in the container containing the numbers. Individuals who have selected numbers from 1 to 45 will be assigned to group A ("Intervention group 1") and those who have chosen numbers 46 to 90 to group B ("Intervention group 2"), those who have selected numbers 91 to 135 to group C ("Intervention group 3") and those who have selected numbers 136 to 180 to group d (control group).
Blinding (investigator's opinion)
Double blinded
Blinding description
After obtaining the consent of the patients to participate in the study and their randomized grouping, the list of members of each group is placed in a sealed envelope; The researcher, clinical caregiver and data analyst remain unaware of the intervention received by the patients until the end of the study, for this case, similar drug packaging with special codes will be used; Unless there is an acute clinical problem for the patient that needs to be removed from the study and it is necessary to know the received intervention, for example, the development of an anaphylactic reaction due to the received intervention. At the end of the study, the list of members and the intervention they received will be determined by opening the sealed envelope.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Khorramabad University of Medical Sciences
Street address
University of Medical Sciences,Shahid Anoushirvan Rezaei Square,Moalem St.,Lorestan, Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2021-12-21, 1400/09/30
Ethics committee reference number
IR.LUMS.REC.1400.241
Health conditions studied
1
Description of health condition studied
Hemorrhoid
ICD-10 code
K64
ICD-10 code description
Hemorrhoids and perianal venous thrombosis
Primary outcomes
1
Description
Pain due to hemorrhoid disease after using the ointment
Timepoint
Days 0, 3, 7, 14, 21 after the start of the intervention
Method of measurement
Assignment of a score between 1 to 10 by the patient
2
Description
Itching due to hemorrhoid disease after using the ointment
Timepoint
Days 0, 3, 7, 14, 21 after the start of the intervention
Method of measurement
Assignment of a score between 1 to 4 by the patient
3
Description
Bleeding due to hemorrhoid disease after using the ointment
Timepoint
Days 0, 3, 7, 14, 21 after the start of the intervention
Method of measurement
Assignment of a score between 1 to 4 by the patient
4
Description
Other side effects after using the ointment
Timepoint
Days 0, 3, 7, 14, 21 after the start of the intervention
Method of measurement
Assignment of a score between 1 to 4 by the patient
5
Description
Patients satisfaction after using the ointment
Timepoint
21 days after the start of the intervention
Method of measurement
very much, much, medium, weak based on the patient's estimation and feeling of satisfaction
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Treated with a combined ointment containing Aburihan anti-hemorrhoid ointment and 1% olive leaf extract (Dana Kasian Company)for 21 days, 3 times a day or as directed by the doctor
Category
Treatment - Drugs
2
Description
Intervention group 2: Treated with a combined ointment containing Aburihan anti-hemorrhoid ointment and 2% olive leaf extract(Dana Kasian Company) for 21 days, 3 times a day or as directed by the doctor
Category
Treatment - Drugs
3
Description
Intervention group 3: Treated with a combined ointment containing Aburihan anti-hemorrhoid ointment and 4% olive leaf extract(Dana Kasian Company) for 21 days, 3 times a day or as directed by the doctor
Category
Treatment - Drugs
4
Description
Control group: Treated with anti-hemorrhoid ointment available in the pharmaceutical market from Aburihan company for 21 days, 3 times a day or as directed by the doctor